Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT01032200
First received: December 13, 2009
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain.

PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.


Condition Intervention Phase
Brain Tumors
Nervous System Tumors
Cognition Disorders
Fatigue
Drug: Armodafinil
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of Armodafinil for Brain Radiation-Induced Fatigue

Resource links provided by NLM:


Further study details as provided by Wake Forest Cancer Center CCOP Research Base:

Primary Outcome Measures:
  • Estimate accrual, adherence, retention, and participation of primary brain tumor patients undergoing partial or whole-brain RT who are randomized to receive armodafinil. [ Time Frame: 9 - 11 Weeks ] [ Designated as safety issue: No ]

    PRIMARY

    • To estimate accrual, adherence, retention, and participation of primary brain tumor patients undergoing partial- or whole-brain RT who are randomized to receive armodafinil (150mg/daily), a CNS stimulant, or placebo.
    • To estimate the variability of fatigue, quality of life, and neurocognitive function in this patient population.


Secondary Outcome Measures:
  • Toxicity as measured by the CTEP active version of the CTCAE [ Time Frame: 9 - 11 Weeks ] [ Designated as safety issue: Yes ]
    - To estimate the rates of toxicity and adverse events associated with armodafinil.

  • Fatigue as measured by the FACIT-F and Brief Fatigue Inventory [ Time Frame: 9 - 11 Weeks ] [ Designated as safety issue: No ]
  • Overall quality of life and brain-specific quality of life [ Time Frame: 9 - 11 Weeks ] [ Designated as safety issue: No ]
    - Measured by the FACT-G with the brain (BR) subscale

  • Sleepiness as measured by the Epworth Sleep Scale [ Time Frame: 9 - 11 Weeks ] [ Designated as safety issue: No ]
  • Cognitive function as measured by the Wake Forest Cognitive Function Battery [ Time Frame: 9 - 11 Weeks ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: August 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Drug: Armodafinil
Given orally
Other Name: Armodafinil
Placebo Comparator: Arm II
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To estimate study accrual, adherence, retention, and participation of patients with primary brain tumors undergoing partial- or whole-brain radiotherapy who are randomized to receive armodafinil or placebo.
  • To estimate the variability of fatigue, quality of life, and neurocognitive function in these patients.

Secondary

  • To obtain a preliminary estimate of the effect of armodafinil on fatigue as measured by the fatigue subscale of the FACIT-F and the Brief Fatigue Inventory.
  • To estimate the rates of toxicity and adverse events associated with armodafinil.
  • To obtain preliminary estimates of the effect of armodafinil on sleepiness as measured by the Epworth Sleep Scale; overall quality of life and brain-specific quality of life as measured by the FACT-G with the brain subscale; and cognitive function as measured by a comprehensive Wake Forest Cognitive Function Battery.

OUTLINE: This is a multicenter study. Patients are stratified according to therapy (radiotherapy alone vs radiotherapy and chemotherapy) and Karnofsky performance status (60-80% vs 90-100%). Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Patients complete questionnaires assessing fatigue, quality of life, and neurocognitive function at baseline and periodically during study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary brain tumor, including any of the following:

    • Glioblastoma multiforme
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Low-grade glioma
    • Meningioma
    • Ependymoma
    • Other primary brain tumor histologies
  • Planning to undergo external-beam cranial radiotherapy (partial- or whole-brain radiotherapy) meeting all of the following criteria:

    • Total dose ≥ 4,500 cGy
    • Total number of fractions ≥ 25 fractions
    • Dose per fraction ≥ 150 cGy

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Hemoglobin ≥ 10.0 g/dL (erythropoietin or transfusion allowed for symptomatically anemic patients with a hemoglobin < 10 g/dL)
  • Creatinine ≤ 2 mg/dL
  • Total bilirubin ≤ 2 times upper limit of normal (ULN)
  • SGOT and SGPT ≤ 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Sexually active women of childbearing potential must use a reliable method of birth control

    • It is recommended that patients use non-hormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month following treatment with armodafinil
  • Prior malignancies allowed
  • No baseline headaches (i.e., headaches occurring in the week before baseline assessment) of grade 4 severity (defined as severe and disabling headaches, requiring analgesics, and interfering with and preventing function or activities of daily living)
  • No concurrent uncontrolled illness that may cause fatigue; interfere with drug absorption, distribution, metabolism, or excretion; or limit compliance with study requirements including, but not limited to, any of the following:

    • Ongoing or active infection
    • Chronic renal insufficiency
    • Psychiatric illness (psychosis, psychotic disorder, history of suicide attempt, or actively suicidal)
    • Extreme social situations (e.g., transportation issues that would preclude study compliance)
  • Patients with a history of cardiac issues (symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) should not use armodafinil as it may cause chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG
  • No history of allergic reaction attributed to modafinil or armodafinil
  • No anticipated or planned excessive consumption of coffee, tea, and/or caffeine-containing beverages averaging > 600 mg of caffeine/day (i.e., approximately 6 cups of coffee/day, 12 cups of hot tea/day, or 12 cans of cola/day)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior fractionated external-beam cranial radiotherapy
  • More than 30 days since prior monoamine oxidate inhibitors or investigational drugs
  • More than 2 weeks since prior and no concurrent modafinil (Provigil), donepezil (Aricept), memantine hydrochloride (Namenda), methylphenidate (Ritalin), dextroamphetamine-amphetamine (Adderall), ginkgo biloba, or any other cognitive function-enhancing drugs
  • At least 4 weeks since prior and no concurrent interstitial or intracavitary chemotherapy and/or radiotherapy or stereotactic radiosurgery (i.e., Gamma Knife, Linac, or Cyberknife)
  • No concurrent erythropoietin, transfusion, or iron therapy (unless patient is symptomatically anemic with hemoglobin < 10 g/dL)
  • Concurrent chemotherapy allowed
  • Concurrent hormonal therapy for other malignancies allowed

    • No concurrent non-hormonal therapy (e.g., Herceptin and other targeted agents), or cytotoxic chemotherapy
  • No concurrent clopidogrel bisulfate (Plavix)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032200

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest Cancer Center CCOP Research Base
Investigators
Principal Investigator: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier: NCT01032200     History of Changes
Other Study ID Numbers: CCCWFU97509, U10CA081851
Study First Received: December 13, 2009
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Cancer Center CCOP Research Base:
adult subependymal giant cell astrocytoma
fatigue
cognitive/functional effects
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult diffuse astrocytoma
adult pilocytic astrocytoma
adult pineal gland astrocytoma
adult oligodendroglioma
adult anaplastic ependymoma
adult ependymoma
adult myxopapillary ependymoma
adult subependymoma
adult anaplastic meningioma
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
adult papillary meningioma
adult brain stem glioma

Additional relevant MeSH terms:
Fatigue
Neoplasms
Brain Neoplasms
Nervous System Neoplasms
Cognition Disorders
Signs and Symptoms
Central Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014